Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-215-05
Reported: March 14, 2018 Initiated: February 21, 2018 #D-0577-2018
Product Description
Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-215-05
Reason for Recall
Failed Stability Specification: OOS low viscosity results discovered during retain testing.
Details
- Recalling Firm
- Akorn, Inc.
- Units Affected
- 31,812 bottles
- Distribution
- Nationwide in the USA
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-215-05. Recalled by Akorn, Inc.. Units affected: 31,812 bottles.
Why was this product recalled? ▼
Failed Stability Specification: OOS low viscosity results discovered during retain testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 14, 2018. Severity: Low. Recall number: D-0577-2018.
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